Hormonal Management of Heavy Menstrual Bleeding in Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heavy Menstrual Bleeding, Bleeding Disorder. Basic parameters: up to 25 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hormonal Management of Heavy Menstrual Bleeding in Adolescents and Young Adults With and Without a Bleeding Disorder: a Prospective Observational Cohort Study
Overview
The goal of this study is to evaluate whether hormonal medications (such as contraceptive pill, patch, injectable progestins and hormonal intra-uterine device) have similar efficacy at managing heavy menstrual bleeding in adolescents with a bleeding disorder compared to those without. We also aim to assess the quality of life and hemoglobin and iron levels in this population.
Detailed description
Adolescents with heavy menstrual bleeding and willing to start a hormonal medication to reduce menstrual flow are included. At baseline and during the study period, questionnaires and blood tests are performed. Adolescents with a bleeding disorder are compared to those without. Follow-up is 1 year.
Primary outcome measures
- Percentage of reduction in menstrual blood loss [Time frame: 6 months after hormonal medication initiation]
Secondary outcome measures (5)
- Percentage of reduction in menstrual blood loss [Time frame: 3 months following hormonal medication initiation]
- Percentage of reduction in menstrual blood loss [Time frame: 12 months after hormonal medication initiation]
- Quality of life [Time frame: at baseline, 3 months, 6 months and 12 months]
- Hemoglobin and ferritin levels changes [Time frame: at baseline, 6 months and 12 months]
- Changes in thrombin generation markers [Time frame: at baseline and 6 months]
Eligibility criteria
Inclusion criteria
- Adolescents and young adults aged < 26yo
- Presenting to the gynecology consultation at HUG
- Diagnosed with heavy menstrual bleeding (PBAC > 100)
- Willing to initiate a hormonal medication to manage heavy menstrual bleeding
Exclusion criteria
- Pregnancy or planning to become pregnant during the study period
- Already using hormonal medication for menstrual management and/or contraception
- Known anatomical uterine pathology
- Using anticoagulant or antiaggregant agents
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Geneva University Hospitals — Geneva
Identifiers
NCT: NCT06740929 · 2024-01578